510(k) · Cleared
ClearedSynthes (Usa) Synthes MMFS-Adjustable Sagittal Split Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · JEY Plate, Bone
Cleared on Dec 13, 1996 after a 44-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 35 later devices descend from it.
- Decided
- Dec 13, 1996
- Review
- 44 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 0
35 later devices descend from it, 1 citing it directly.
- This deviceK964328 Synthes (Usa) Synthes MMFS-Adjustable Sagittal Split PlateSynthes (Usa) · 1996
- Descendant · cites it directly · 34 of its ownK993862 Modus Sagittal Split PlateThe Straumann Co. · 1999
- Descendant · 2 generations on · 33 of its ownK022185 Universal CMF SystemStryker Instruments · 2002
- Descendant · 3 generations on · 12 of its ownK031659 Universal Neuro SystemStryker Instruments · 2003
- Descendant · 4 generations on · 9 of its ownK112557 Stryker Universal Neuro 3 SystemStryker · 2012
- Descendant · 5 generations on · 4 of its ownK120352 Stryker Quikflap Sterile Procedure PackStryker · 2012 · Recalled
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K993862Modus Sagittal Split PlateThe Straumann Co. · 1999 · cites it directly34descendants
- K022185Universal CMF SystemStryker Instruments · 2002 · 2 generations on33descendants
- K031659Universal Neuro SystemStryker Instruments · 2003 · 3 generations on12descendants
- K112557Stryker Universal Neuro 3 SystemStryker · 2012 · 4 generations on9descendants
- K120352Stryker Quikflap Sterile Procedure PackStryker · 2012 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964328 | Synthes (Usa) Synthes MMFS-Adjustable Sagittal Split Plate | Synthes (Usa) | 1996 | — |
| +1 | K993862 | Modus Sagittal Split Plate | The Straumann Co. | 1999 | — |
| +2 | K022185 | Universal CMF System | Stryker Instruments | 2002 | — |
| +3 | K031659 | Universal Neuro System | Stryker Instruments | 2003 | — |
| +4 | K112557 | Stryker Universal Neuro 3 System | Stryker | 2012 | — |
| +5 | K120352 | Stryker Quikflap Sterile Procedure Pack | Stryker | 2012 | 18 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JEY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JEY device
- #1 K252246 Leforte MMF Systemscore 15.6 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (35)
See all 351 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993862 | Modus Sagittal Split Plate | 1999 | 34 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K993862 (The Straumann Co., 1999) has gone furthest, with 34 descendants of its own.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JEY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JEY
159in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JEY
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JEY
1,003in 2025
MAUDE reports naming product code JEY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 9 | 115 | 0 | 29 |
| 2008 | 7 | 84 | 3 | 24 |
| 2009 | 4 | 121 | 6 | 93 |
| 2010 | 6 | 199 | 85 | 215 |
| 2011 | 5 | 75 | 0 | 241 |
| 2012 | 10 | 194 | 0 | 428 |
| 2013 | 8 | 126 | 1 | 766 |
| 2014 | 6 | 223 | 0 | 616 |
| 2015 | 7 | 160 | 0 | 767 |
| 2016 | 1 | — | 0 | 558 |
| 2017 | 5 | 190 | 0 | 568 |
| 2018 | 7 | 255 | 0 | 608 |
| 2019 | 6 | 163 | 0 | 595 |
| 2020 | 6 | 198 | 1 | 680 |
| 2021 | 4 | 299 | 0 | 451 |
| 2022 | 5 | 135 | 0 | 344 |
| 2023 | 2 | — | 0 | 495 |
| 2024 | 5 | 159 | 0 | 696 |
| 2025 | 2 | — | 0 | 1,003 |
| 2026 | 3 | 258 | 0 | — |
https://510kreport.com/device/K964328 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964328: Synthes (Usa) Synthes MMFS-Adjustable Sagittal Split Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964328
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026